[Federal Register Volume 63, Number 142 (Friday, July 24, 1998)] [Proposed Rules] [Pages 39763-39765] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-19805] ======================================================================= ----------------------------------------------------------------------- NUCLEAR REGULATORY COMMISSION 10 CFR Part 35 Medical Use of Byproduct Material; Public Meetings AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of public meetings. ----------------------------------------------------------------------- SUMMARY: The Nuclear Regulatory Commission has developed a proposed rulemaking for a comprehensive revision of its regulations governing the medical use of byproduct material in 10 CFR Part 35, ``Medical Use of Byproduct Material,'' and a proposed revision of its 1979 Medical Use Policy Statement (MPS). Throughout the development of the proposed rule and MPS, the Commission solicited input from the various interests that may be affected by these proposed revisions. The Commission now plans to solicit comments on the proposed rule and MPS through two mechanisms--publishing the documents in the Federal Register for public comment (scheduled for August 1998); and convening three facilitated public meetings, during the public comment period, to discuss the Commission's proposed resolution of the major issues. The public meetings will be held in San Francisco, California, on August 19-20, 1998; in Kansas City, Missouri, on September 16-17, 1998; and in Rockville, Maryland, on October 21-22, 1998. All meetings will be open to the public. Francis X. Cameron, Special [[Page 39764]] Counsel for Public Liaison, in the Commission's Office of the General Counsel, will be the convener and facilitator for the meetings. DATES: The first public meeting will be in San Francisco on August 19- 20, 1998, from 8:30 a.m. to 5:00 p.m. each day; the second public meeting will be in Kansas City on September 16-17, 1998, from 8:30 a.m. to 5:00 p.m. each day; and the third public meeting will be in Rockville on October 21-22,1998, from 8:30 a.m. to 5:00 p.m. each day. ADDRESSES: The San Francisco meeting will be held at the ANA Hotel San Francisco, 50 Third Street, San Francisco, California 94103, 415-974- 6400. The Kansas City meeting will be held at the Radisson Suite Hotel Kansas City, Kansas City, 106 West 12th Street, Kansas City, MO 64105, 800-333-3333. The Rockville meeting will be held in the auditorium at the U.S. Nuclear Regulatory Commission, 11545 Rockville Pike, Rockville, MD 20852-2738. FOR FURTHER INFORMATION CONTACT: Francis X. Cameron, Special Counsel for Public Liaison, Office of the General Counsel, Nuclear Regulatory Commission, Washington D.C. 20555-0001, Telephone: 301-415-1642. SUPPLEMENTARY INFORMATION: Background Following a comprehensive review of its medical use program, the Commission directed the NRC staff to revise 10 CFR Part 35, associated guidance documents, and, if necessary, the Commission's 1979 Medical Policy Statement [Staff Requirements Memorandum (SRM)--COMSECY-96-057, Materials/Medical Oversight (DSI 7), dated March 20, 1997]. The Commission's SRM specifically directed the restructuring of Part 35 into a risk-informed, more performance-based regulation. In its SRM dated June 30, 1997, ``SECY-97-115, Program for Revision of 10 CFR Part 35, `Medical Uses of Byproduct Material' and Associated Federal Register Notice,'' the Commission approved the NRC staff's proposed plan for the revision of Part 35 and the Commission's 1979 Medical Use Policy Statement (MPS). The schedule approved by the Commission in SRM- SECY-97-115 provides for the rulemaking to be completed by June 1999. After Commission approval of the NRC staff's program to revise Part 35 and associated guidance documents, the NRC staff initiated the rulemaking process, as announced in 62 FR 42219 (August 6, 1997). The proposed rule and MPS were developed using a group approach. A Working Group and Steering Group, consisting of representatives of NRC, the Organization of Agreement States, and the Conference of Radiation Control Program Directors, were established to develop rule text alternatives, rule language, and associated guidance documents. State participation in the process was intended to enhance development of corresponding rules in State regulations, to provide an opportunity for early State input, and to allow State staff to assess potential impacts of NRC draft language on the regulation of non-Atomic Energy Act materials used in medical diagnosis, treatment, or research, in the States. The proposed revision of Part 35 is based on the Commission's directions in the SRMs of March 20, 1997, and June 30, 1997. The revision is intended to make Part 35 a more risk-informed, performance- based regulation that will focus the regulations on those medical procedures that pose the highest risk, from a radiation safety aspect, with a subsequent decrease in the oversight of low-risk activities; focus on those requirements that are essential for patient safety; initiate improvements in NRC's medical program, by implementing recommendations from internal staff audits, other rulemaking activities, and results of analyses in medical issues papers; incorporate regulatory requirements for new treatment modalities; and reference, as appropriate, available industry guidance and standards. As part of the rulemaking process, significant issues associated with the regulation of the medical use of byproduct material and the revision of the MPS were identified, alternatives were developed for them, and public input on them was specifically sought. These alternatives were developed to stimulate input from members of the public in an effort to encourage all interested parties to contribute to the development of the revised regulation and were discussed during facilitated public workshops and meetings throughout the development of the proposed rule and MPS. The program for revising Part 35, associated guidance document, and MPS has provided more opportunity for input from potentially affected parties (the medical community and the public) than is provided by the typical notice and comment rulemaking process. Early public input was solicited by requesting input through Federal Register notices; holding public meetings of the Working and Steering Groups; meeting with medical professional societies and boards; putting background documents, rulemaking alternatives, and a ``strawman'' draft proposed rule on the Internet and in NRC's Public Document Room; and convening two facilitated public workshops. Significant regulatory issues were also discussed at the Part 35 Workshop that was held in conjunction with the All Agreement States Meeting in October 1997, the Advisory Committee on the Medical Uses of Isotopes (ACMUI) meetings in September 1997 and March 1998, and the ACMUI subcommittee meetings in February 1998. Input received during these interactions and in writing were beneficial to the staff in developing the proposed rule and MPS. Workshops Based on the substantive public input received during the early rulemaking process, the Commission believes that it is important for interests affected by the proposed revisions to have an opportunity to comment on the proposed rulemaking and MPS, as well as have an opportunity to discuss the proposed revisions with one another and the Commission. Accordingly, the Commission is convening three public meetings, during the public comment period, where representatives of the interests that may be affected by the proposed rulemaking and MPS will have an opportunity to discuss the proposed revisions. Although the meetings are intended to foster a clearer understanding of the positions and concerns of the affected interests, as well as to identify areas of agreement or disagreement, it is not the intent of the meetings to develop a consensus agreement of the participants on the rulemaking issues. To have a manageable discussion, the number of participants in each meeting will be limited. The Commission, through the facilitator for the meeting, will attempt to ensure participation by the broad spectrum of interests that may be affected by the proposed rulemaking and MPS. These interests include: nuclear medicine physicians; physician specialists, such as cardiologists and radiologists; medical physicists; medical technologists; nurses; medical education and certification organizations; radiopharmaceutical interests; hospital administrators; radiation safety officers; patients' rights advocates; Agreement States; Federal agencies; and experts in risk analysis. Other members of the public are welcome to attend, and the public will have the opportunity to comment on the proposed rulemaking and MPS and to participate in the meeting discussions at periodic intervals. Questions about participation [[Page 39765]] may be directed to the facilitator, Francis X. Cameron. The meetings will have a pre-defined scope and agenda focused on the Commission's resolution of the major issues addressed during the development of the proposed rule and MPS. However, the meeting format will be sufficiently flexible to allow for the introduction of additional related issues that the participants may want to raise. The meeting commentary will be transcribed and made available to the participants and the public. Copies of the proposed revision of Part 35 and the MPS will be provided to the meeting participants. Also, copies will be available for members of the public in attendance at the meetings. The availability of the proposed rule, and associated documents, and the MPS for individuals who are unable to attend any of the public meetings will be noted in the Federal Register notices for these documents. Public comments on the proposed rule and MPS are solicited but, to be most helpful, should be received by the date that will be announced in the Federal Register notices on the proposed rule and MPS. Comments received after this date will be considered if it is practical to do so, but the Commission only is able to ensure consideration of comments received on or before this date. Written input and suggestions can be sent to Secretary, Nuclear Regulatory Commission, Washington, DC 20555- 0001, Attention: Rulemakings and Adjudications Staff. Hand-deliver comments to 11555 Rockville Pike, Rockville, MD, between 7:30 a.m. and 4:15 p.m. on Federal workdays. Dated at Rockville, Maryland this 17th day of July, 1998. For the Nuclear Regulatory Commission. Frederick C. Combs, Acting Director, Division of Industrial and Medical Nuclear Safety, Office of Nuclear Material Safety and Safeguards. [FR Doc. 98-19805 Filed 7-23-98; 8:45 am] BILLING CODE 7590-01-P